Safety of MenACWY-CRM Vaccination in Adolescents

Completed

Conditions studied: Meningococcal Disease

In brief

The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.

Key facts

Study ID

NCT01452464

Run by

Novartis Vaccines

People needed

55397

Starts

2011-09-01

Expected to finish

2015-02-01

Last updated by the study team

2015-02-26

Who can join

Age: 11 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Enrolled in the HMO for at least 6 months prior to vaccination
• Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.
• Received the vaccine during the study period

Where it is running

• Riverside Medical Center Campus, 10800 Magnolia Ave — Riverside, California, United States
• San Diego Medical Center Campus, 4647 Zion Ave 92120 — San Diego, California, United States
• Fontana Medical Center Campus — Valley Annex, 16994 E. Valley Blvd., Fontana, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.